Specialist, Quality Compliance

Edwards Lifesciences • Indianapolis, IN

1d

About The Position

The Specialist, Quality Compliance supports quality compliance activities and business outcomes for Edwards’ Transcatheter Mitral and Tricuspid Therapies business unit. The role applies professional expertise and judgment to assess and investigate product complaints, collaborate with internal teams, determine regulatory reporting needs, and communicate investigation outcomes to customers. The position contributes to process improvements and may assist with auditing complaint files.

Requirements

• At least 3 years of experience in complaint handling or equivalent work experience based on Edwards criteria.
• Experience working in a medical device, healthcare, or related environment, or equivalent work experience based on Edwards criteria.
• Demonstrated problem-solving, critical-thinking, and investigative skills.
• Excellent written and verbal communication and interpersonal relationship skills.
• Ability to build stable and productive internal and external working relationships.
• Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance.
• Good knowledge of medical terminology and human anatomy.
• Full knowledge of Medical Device Reporting regulations and regulatory reporting regulations.
• Good knowledge of Good Documentation Practices as they relate to complaint filing.
• Ability to manage confidential information with discretion and strong attention to detail.
• Ability to interact professionally with all organizational levels and manage competing priorities in a fast-paced environment.
• Ability to work in a team environment, including interdepartmental teams, and represent the department on specific projects.
• Adherence to company rules and requirements, including pandemic protocols and Environmental Health & Safety rules, and taking adequate control measures to prevent injuries and pollution and protect the environment within their span of influence or control.

Nice To Haves

• Proven expertise in the MS Office Suite and ability to operate general office machinery.
• Medical device experience involving cardiovascular, endovascular, or other critical care or surgical products.

Responsibilities

• Assess complaint information, determine whether each event qualifies as a complaint, and escalate as appropriate.
• Manage customer relationships and expectations throughout complaint investigation and resolution.
• Research and obtain information and input from Product Safety, Engineering, and other departments or business units for complaint investigations; challenge input as appropriate.
• Identify problems and lead projects to improve processes, procedures, or practices, recommending solutions and developing new approaches where needed.
• Evaluate complaints for Medical Device Reporting (MDR) requirements and prepare and submit MDR reports to the FDA.
• Summarize investigation findings, including relevant investigation details, product analysis, imaging review, instructions for use, labeling, and training materials, and formulate conclusions.
• Prepare and submit final customer correspondence.
• Perform other duties assigned by leadership; may assist in auditing complaint files.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed